Using zoledronic acid-loaded bone cement to reduce recurrence of giant cell bone tumors after surgery
Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.
This study tests if using a special bone cement with a drug can help prevent giant cell bone tumors from coming back after surgery, compared to regular bone cement.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 153 (estimated) |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | denosumab |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05595603 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of zoledronic acid-loaded bone cement as an adjuvant therapy to decrease local recurrence rates in patients with giant cell tumors of the bone following intralesional curettage surgery. The study compares the outcomes of patients receiving this specialized bone cement to those receiving traditional gentamicin PMMA bone cement. Additionally, it evaluates secondary outcomes such as functional improvement and surgery-related complications. The trial aims to provide insights into the potential benefits of local drug delivery in surgical oncology.
Who should consider this trial
Good fit: Ideal candidates are patients with primary resectable giant cell tumors of the bone who are undergoing intralesional curettage.
Not a fit: Patients with recurrent or extensive giant cell tumors that are not amenable to curettage surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of giant cell bone tumors, improving patient outcomes and quality of life.
How similar studies have performed: While the use of local adjuvant therapies is common, the specific approach of using zoledronic acid-loaded bone cement is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with primary resectable GCT of bone * lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal * no previous systemic bisphosphonate or denosumab therapy * with expected longer than 18 months of survival time * sign the informed consent form Exclusion Criteria: * patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature. * conduct unexpected surgery at other center * the primary goal for surgery is revision * patient conduct en-bloc/wide resection instead of curettage surgery * patient can not conduct self-assessment during follow up * difficulty in complete postoperative follow-up * previous use of bisphosphonate/ZOL or denosumab drug * patients have participated in similar research projects * refused to sign informed consent
Where this trial is running
Hangzhou
- The Second Affiliated Hospital of Zhejiang University — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Meng Liu, MD
- Email: liumeng80@163.com
- Phone: 13515711791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.